Limited reuse ablation needles and ablation devices for use therewith

ABSTRACT

A surgical instrument includes a reusable component and a limited-use component releasably engagable with the reusable component. The limited-use component is configured for one or more uses and includes a clocking mechanism configured to count each engagement of the reusable component and the limited-use component to one another. The clocking mechanism is incrementally transitionable upon each successive count from one or more uses state, wherein the clocking mechanism permits both mechanical engagement and electrical coupling of the reusable component and the limited-use component to one another, to a spent state, wherein the clocking mechanism inhibits both mechanical engagement and electrical coupling of the limited-use component and the reusable component to one another.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. patentapplication Ser. No. 15/181,042, now U.S. Pat. No. 9,700,370, which is acontinuation application of U.S. patent application Ser. No. 13/460,440,filed on Apr. 30, 2012, now U.S. Pat. No. 9,364,278, the entire contentsof each of which are incorporated herein by reference.

BACKGROUND Technical Field

The present disclosure relates to surgical instruments and, moreparticularly, to ablation devices including disposable needlesconfigured for single-use or a limited amount and/or number of uses.

Background of Related Art

Energy-based tissue treatment is well known in the art. Various types ofenergy (e.g., electrosurgical, ultrasonic, microwave, cryogenic,thermal, laser, etc.) are applied to tissue to achieve a desired result,e.g., to cut, ablate, coagulate, and/or seal tissue.

Electrosurgery involves the application of radio frequency (RF) energyto a surgical site to cut, ablate, coagulate, and/or seal tissue. Inmonopolar electrosurgery, a source or active electrode, which istypically part of the surgical instrument held by the surgeon, deliversRF electrical current from a generator to tissue, while a patient returnelectrode is placed remotely from the active electrode to carry thecurrent back to the generator.

In tissue ablation electrosurgery, for example, the RF energy may bedelivered to targeted tissue by a probe or needle. More specifically, inuse, the needle is typically advanced through tissue to a desiredposition either prior to or during application of energy to tissue.After repeated use, these needles may become dull, bent, or otherwisedeformed and, consequently, may become more difficult to place andoperate upon subsequent use. As such, ablation devices have beendeveloped which include replaceable needles, thus allowing the needle tobe replaced after one or more uses without requiring replacement of theentire device (e.g., the handpiece).

SUMMARY

As used herein, the term “distal” refers to the portion that is beingdescribed which is further from a user, while the term “proximal” refersto the portion that is being described which is closer to a user.Further, to the extent consistent with one another, any of the aspectsdescribed herein may be used in conjunction with any of the otheraspects described herein.

In accordance with aspects of the present disclosure, a surgicalinstrument is provided generally including a reusable component and alimited-use component releasably engagable with the reusable component.The limited-use component is configured for one or more uses andincludes a clocking mechanism configured to count each engagement of thereusable component and the limited-use component to one another. Theclocking mechanism is incrementally transitioned upon each successivecount from one or more use states (corresponding to the number of usesof the limited-use component), wherein the clocking mechanism permitsboth mechanical engagement and electrical coupling of the reusablecomponent and the limited-use component to one another, to a spentstate, wherein the clocking mechanism inhibits both mechanicalengagement and electrical coupling of the limited-use component and thereusable component to one another.

In one aspect, the limited-use component is configured for apre-determined plurality of uses. In such an aspect, the clockingmechanism is incrementally transitionable from a plurality of usestates, each corresponding to one of the pre-determined plurality ofuses, to the spent state.

In still another aspect, the clocking mechanism includes a hub and ahousing. The hub is disposed within the housing and is rotatably andlongitudinally movable relative to the housing to incrementallytransition the clocking mechanism from the one or more use states to thespent state. Further, the housing may defines a three-dimensional trackon an interior surface thereof that is configured to guide translationand rotation of the hub relative to the housing.

In yet another aspect, the reusable component includes a contact memberconfigured for insertion into the limited-use component for mechanicallyengaging the reusable component and the limited-use component to oneanother and for triggering a count of the clocking mechanism.

In still yet another aspect, the clocking mechanism further includesindicia configured to display a condition of the limited-use component.More specifically, the indicia may be configured to displays a number ofuses remaining for the limited-use component.

In another aspect, the clocking mechanism is further transitionable to alocked state to inhibit manual overriding of the clocking mechanism.

In yet another aspect, the surgical instrument includes an ablationdevice having a reusable handle assembly and a limited-use electrodeassembly that is releasably engagable with the reusable handle assembly.

In still another aspect, the reusable component is configured to supplyfluid to the limited-use component. In such an aspect, the supply offluid to the limited-use component may trigger a count of the clockingmechanism.

An ablation device provided in accordance with aspects of the presentdisclosure generally includes a reusable handle assembly configured toconnect to a source of energy and including a contact member. Alimited-use electrode assembly is configured receive the contact memberof the reusable handle assembly for mechanically engaging andelectrically coupling the reusable handle assembly and the limited-useelectrode assembly for transmitting energy to tissue to treat tissue.The limited-use electrode assembly is configured for one or more usesand includes a clocking mechanism. The clocking mechanism is configuredto count each use of the limited-use electrode assembly and toincrementally transition upon each successive count from the one or moreuse states, wherein engagement of the reusable handle assembly and thelimited-use electrode assembly is permitted, to a spent state, whereinthe clocking mechanism inhibits engagement of the limited-use electrodeassembly and the reusable handle assembly to one another. Insertion ofthe contact member of the reusable handle assembly into the limited-useelectrode assembly triggers a count of the clocking mechanism.

In one aspect, the clocking mechanism further includes indiciaconfigured to display a condition of the limited-use electrode assembly.More specifically, the indicia may be configured to display a number ofuses remaining for the limited-use electrode assembly.

In another aspect, the limited-use electrode assembly is configured fora pre-determined plurality of uses. In such an aspect, the clockingmechanism is incrementally transitionable from a plurality of usestates, each corresponding to one of the pre-determined plurality ofuses, to the spent state.

In still another aspect, the clocking mechanism is furthertransitionable to a locked state to inhibit manual overriding of theclocking mechanism.

Provided in accordance with aspects of the present disclosure is asurgical instrument generally including a reusable component configuredto connect to a source of fluid and a limited-use component releasablyengagable with the reusable component. The limited-use component isconfigured to receive fluid from the reusable component and includes aclocking mechanism. The clocking mechanism is configured to count eachsuccessive use of the limited-use component upon supply of fluid to thelimited-use component and to incrementally transition upon eachsuccessive count from one or more use states, wherein the clockingmechanism permits both mechanical engagement and electrical coupling ofthe reusable component and the limited-use component to one another, toa spent state, wherein the clocking mechanism inhibits both mechanicalengagement and electrical coupling of the limited-use component and thereusable component to one another.

In one aspect, the limited-use component is configured for apre-determined plurality of uses. Accordingly, the clocking mechanism isincrementally transitionable from a plurality of use states, eachcorresponding to one of the pre-determined plurality of uses, to thespent state.

In still another aspect, the clocking mechanism further includes indiciaconfigured to display a condition of the limited-use component. Morespecifically, the indicia may be configured to display a number of usesremaining for the limited-use component.

In yet another aspect, the surgical instrument includes an ablationdevice having a reusable handle assembly and a limited-use electrodeassembly releasably engagable with the reusable handle assembly.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects of the present disclosure are described herein withreference to the drawings wherein like reference numerals identifysimilar or identical elements:

FIG. 1 is a side view of an electrosurgical ablation system provided inaccordance with the present disclosure;

FIG. 2 is a longitudinal, cross-sectional view of a distal end of theelectrosurgical ablation system of FIG. 1 with a needle electrodeassembly disengaged from a handle assembly thereof;

FIG. 3 is a longitudinal, cross-sectional view of the electrosurgicalablation system of FIG. 1 with the needle electrode assembly engaged tothe handle assembly;

FIG. 4 is a longitudinal, cross-sectional view of the needle electrodeassembly of the electrosurgical ablation system of FIG. 1, wherein aclocking mechanism of the needle electrode assembly is disposed in alocked-out condition;

FIG. 5A is a schematic illustration of an interior surface of a housingof the needle electrode assembly of the electrosurgical ablation systemof FIG. 1, illustrating a hub of the clocking mechanism moving relativethereto;

FIG. 5B is a schematic illustration of an interior surface of the hub ofthe needle electrode assembly of the electrosurgical ablation system ofFIG. 1, illustrating a contact pin of the handle assembly movingrelative thereto;

FIG. 6A is a longitudinal, cross-sectional view of a distal end ofanother electrosurgical ablation device provided in accordance with thepresent disclosure, showing a needle electrode assembly and handleassembly during engagement to one another; and

FIG. 6B is a transverse, cross-sectional view of a clocking mechanism ofthe electrosurgical ablation system of FIG. 6A.

DETAILED DESCRIPTION

Referring initially to FIGS. 1-2, an ablation system provided inaccordance with the present disclosure is shown generally designated byreference numeral 10. Although ablation system 10 is shown configured asan RF-ablation system 10, the present disclosure is equally applicablefor use with microwave ablation systems, or any other suitable surgicalsystem including single-use or limited-use disposable components.Obviously, different considerations apply depending on the particulardevice and/or system used; however, the novel aspects with respect toinhibiting or limiting re-use of the needle (or other component) remainsgenerally consistent regardless of the particular type of device and/orsystem used. For the purposes herein, ablation system 10 is generallydescribed.

Continuing with reference to FIGS. 1-2, ablation device 100 of ablationsystem 10 generally includes a handle assembly 110 and a needleelectrode assembly 150 releasably engagable with and extending fromhandle assembly 110. Although only one needle electrode assembly 150 isshown, additional needle electrode assemblies, either similar to ordifferent from needle electrode assembly 150, may be provided forreleasable engagement with handle assembly 110. As such, a desiredneedle electrode assembly may be selected and engaged to handle assembly110, depending on a particular purpose and/or to replace a “spent”needle.

Handle assembly 110 includes a housing 112 which may be ergonomically orotherwise configured to facilitate the grasping and manipulation ofhousing 112 by a user to position needle electrode assembly 150 asdesired. Housing 112 is formed from an insulative material and definesproximal and distal ends 113, 115, respectively. Proximal end 113 ofhousing is configured to receive lines 22, 32 from an energy source,e.g., generator 20, and cooling fluid source 30, respectively, forsupplying energy and cooling fluid, respectively, to needle electrodeassembly 150. Contact pin 122 extends from distal end 115 of housing 112and is configured for insertion into housing 152 of needle electrodeassembly 150 for engaging needle electrode assembly 150 and handleassembly 110 to one another. More specifically, contact pin 122 isinsertable through housing 152 and into engagement within proximal end171 of needle 170, e.g., in friction-fit engagement therewith toreleasably mechanically engage needle electrode assembly 150 and handleassembly 110 to one another. Other releasable engagement mechanisms,e.g., snap-fit engagements, are also contemplated.

With continued reference to FIGS. 1-2, handle assembly 110, as mentionedabove, includes an electrical contact pin 122 (although greater or fewercontacts are also contemplated) extending distally therefrom that isconfigured for insertion into proximal end 171 of needle 170 of needleelectrode assembly 150 to establish electrical communication betweenhandle assembly 110 and needle electrode assembly 150 upon mechanicalengagement of handle assembly 110 and needle electrode assembly 150. Oneor more wires (not explicitly shown) extending through housing 112 ofhandle assembly 110 couple contact pin 122 to line 22, which extendsproximally from housing 112 of handle assembly 110, ultimately couplingto generator 20. As such, power and/or control signals may betransmitted between generator 20 and needle electrode assembly 150. Inparticular, contact pin 122 may be configured for establishing aconductive path for transmission of energy between generator 20 andneedle 170 of needle electrode assembly 150. As such, upon activation,energy can be transmitted from generator 20 to needle electrode assembly150 and, ultimately, conducted through tissue to ablate or otherwisetreat tissue. One or more lumens (not explicitly shown) extendingthrough contact pin 122 may also be provided for circulation of coolingfluid from a cooling fluid source 30 through hollow interior 174 ofneedle 170, similarly as described below with respect to ablation device300 (FIGS. 6A-6B). As an alternative to external generator 20, it iscontemplated that generator 20 be incorporated into handle assembly 110,thus providing a hand-held ablation device 100.

Contact pin 122 (or other electrical contacts (not shown)) mayadditionally or alternatively be utilized for identifying or verifyingthe identification of the particular type of needle electrode assembly150 engaged with handle assembly 110. This feature helps ensure that anacceptable needle electrode assembly 150 has been engaged to handleassembly 110 and/or that the proper energy delivery and controlparameters for the particular needle electrode assembly 150 engaged withhandle assembly 110 are provided by generator 20. Further, the operationof cooling fluid source 30 may also be at least partially dependent uponthe particular type of needle electrode assembly 150 detected. Thus,identifying information for the particular type of needle electrodeassembly 150 engaged to handle assembly 110 may be relayed to andutilized by cooling fluid source 30 for controlling the supply ofcooling fluid to the needle electrode assembly 150 in accordancetherewith. Other configurations of contact(s) or similar features forestablishing electrical communication and electrical energy transmissionbetween handle assembly 110 and needle electrode assembly 150 are alsocontemplated.

Needle electrode assembly 150 defines a longitudinal axis “X-X” andincludes a housing 152 disposed at the proximal end thereof and anelectrically-conductive needle 170 disposed partially within housing 152and extending distally from housing 152. Housing 152 is formed from anelectrically-insulative material and includes an internal cavity 155configured to receive contact pin 122 of handle assembly 110 and needle170 for engagement of contact pin 122 and needle 170 to one another.Internal cavity 155 of housing 152 incorporates a clocking mechanism 200therein that is configured to count the number of uses of needleelectrode assembly 150, e.g., the number of times needle electrodeassembly 150 has been engaged to handle assembly 110, and to inhibitsubsequent use of needle electrode assembly 150 once the pre-determinednumber of uses of needle electrode assembly 150 has been achieved.Clocking mechanism 200 will be described in greater detail below.

Needle 170 of needle electrode assembly 150 defines a hollow interior174 and includes an insulative sleeve (or coating) 180 disposed about aportion of the external surface of needle 170. Proximal end 171 ofneedle 170, as mentioned above, is configured to mechanically engage andelectrical couple to contact pin 122 of handle assembly 110, e.g.,proximal end 171 of needle 170 is configured to extend into housing 152of needle electrode assembly 150 to receive contact pin 122 of handleassembly 110 therein in friction-fit engagement therewith (althoughother suitable engagements are also contemplated), to mechanicallyengage and electrically couple needle electrode assembly 150 and handleassembly 110 to one another. Needle 170 extends distally from housing152 to distal end 176 thereof, which defines a distal tip 178 configuredto facilitate the penetration of tissue while minimizing the risk ofhemorrhage from the puncture tract, although other distal tipconfigurations are also contemplated. Needle 170 is formed from anelectrically-conductive material of which at least distal end 176 isexposed. Insulative sleeve 180 is disposed about a portion of needle 170such that at least distal end 176 of needle 170 exposed. With distal end176 of needle 170 exposed, energy, e.g., RF energy, can be deliveredfrom needle 170 to surrounding tissue to treat, e.g., ablate, tissue.

As mentioned above, an energy source, e.g., generator 20, is providedfor providing power and/or control signals to needle electrode assembly150 via line 22 and contact pin 122. Further, cooling fluid source 30and line 32 are provided for providing cooling fluid to needle electrodeassembly 150, e.g., via one or more lumens (not explicitly shown)extending through contact pin 122 and into communication with hollowinterior 174 of needle 170 (similarly as described below with respect toablation device 300 (FIGS. 6A-6B). That is, cooling fluid source 30provides cooling fluid, via line 32 (which includes both inflow andoutflow lines), such that cooling fluid supplied by the cooling fluidsource 30 may be circulated through hollow interior 174 of needle 170 tomaintain needle electrode assembly 150 in a relatively cooled stateduring the application of energy to tissue. Cooperating valves (notshown) of needle electrode assembly 150 and handle assembly 110 may beprovided to facilitate and/or regulate the passage, e.g., inflow andoutflow, of the cooling fluid between cooling fluid source 30 and hollowinterior 174 of needle 170, although other configurations are alsocontemplated. Circulation of the cooling fluid may be establishedthrough the use of a pump (not shown) or other suitable mechanismdisposed within housing 112 of handle assembly 110, or the pump (notshown) may be externally disposed.

In operation, ablation device 100, led by distal tip 178 of needle 170,is inserted into an operative site such that exposed distal end 176 ofneedle 170 of ablation device 100 is positioned adjacent to or within atarget tissue to be treated, e.g., ablated. A return pad or returnelectrode (not shown) may, at this point or prior to, beoperatively-adhered to or connected to the patient. With exposed distalend 176 of needle 170 in position, energy, e.g., RF energy, is deliveredfrom generator 20 to needle 170 and is conducted from exposed distal end176 of needle 170 through the target tissue, ultimately to be collectedby the return electrode (not shown). An effective amount of energy at aneffective energy level and for an effective duration of time isdelivered to tissue to achieve the desired result, e.g., to treat thetarget tissue. To this end, one or more control switches 130 may beprovided on handle assembly 110 for controlling the supply of energy toneedle 170, or, alternatively, the supply of energy may be automaticallyor manually controlled by generator 20.

Either prior to or simultaneously with the delivery of electrosurgicalenergy to needle 170, the cooling fluid provided by cooling fluid source30 may be circulated through hollow interior 174 of needle 170 towithdraw heat from needle 170, thus maintaining needle 170 in arelatively cooled state during use. The delivery of cooling fluid tohollow interior 174 of needle 170 may likewise be controlled by one ormore control switches 130 disposed on handle assembly 110, or viacooling fluid supply 30 itself.

At the completion of the procedure, needle electrode assembly 150 may bedisengaged from handle assembly 110 and both may be sterilized forreuse. Ultimately, needle electrode assembly 150 may be re-engaged tohandle assembly 110 (or may be engaged to another handle assembly) forsubsequent use. However, although needle electrode assembly 150 isconfigured for repeated use, the number of uses of needle electrodeassembly 150 is limited via clocking mechanism 200, thus inhibitingneedle electrode assembly 150 from being used, e.g., re-engaged tohandle assembly 110 or another handle assembly, beyond thepre-determined number of uses set via clocking mechanism 200. Thefeatures and operation of clocking mechanism 200 are described in detailbelow.

With reference to FIGS. 2-5B, clocking mechanism 200 of ablation device100 generally includes a hub 210 operably disposed within housing 152 ofneedle electrode assembly 150. Housing 152 defines an internal cavity155 and includes a proximal opening 157 in communication with cavity 155that is configured to receive contact pin 122 of handle assembly 110therethrough and a distal opening 159 in communication with cavity 155that is configured to receive needle 170 therethrough. The internalsurface 220 of housing 152 that defines cavity 155 defines a shoulder222 and a three-dimensional track 224 that, as will be described ingreater detail below, are configured to guide translation and rotationof hub 210 relative to housing 152. A spring 250 disposed about needle170 and positioned within cavity 155 between the distal end of housing152 and hub 210 is configured to bias hub 210 proximally. Further, firstand second lock apertures 262 defined within respective lock members 260are configured to engage corresponding lock fingers 264 extendingdistally from hub 210 to lock hub 210 and, thus, needle electrodeassembly 150 in the “spent” condition, as will be described below.Housing 152 also includes a transverse window 160 configured to permitvisualization of hub 210 from the exterior of housing 152 such that theuser may determine the condition of needle electrode assembly 150, e.g.,the number of uses needle electrode assembly 150 has remaining.

Hub 210 of clocking mechanism 200 includes a plurality of angled flanges212 (see FIG. 5A) extending outwardly therefrom. Flanges 212 areinitially disposed in abutting relation with shoulder 222 of housing 152under the bias of spring 250, and are configured to translate alongthree-dimensional track 224 of internal surface 220 of housing 152 to“clock” or count the number of uses of needle electrode assembly 150.Hub 210 further defines a central lumen 230 extending therethrough. Morespecifically, needle 170 extends at least partially into central lumen230 of hub 210 and is engaged therein such that hub 210 is disposed atleast partially about needle 170. Due to this configuration, wherein hub210 and needle 170 are engaged to one another, both hub 210 and needle170 are rotationally and longitudinally movable relative to housing 152.

With continued reference to FIGS. 2-5B, the internal surface 232 of hub210 that defines central lumen 230 defines a track 234 configured toreceive angled protrusions 124 (although only one is shown and describedfor simplicity purposes) disposed about contact pin 122 of handleassembly 110 upon insertion of contact pin 122 through proximal opening157 of housing 152, central lumen 230 of hub 210, and into engagementwith needle 170 for mechanically engaging and electrically couplinghandle assembly 110 and needle electrode assembly 150 to one another. Aswill be described in greater detail below, angled protrusion 124facilitates the rotation of hub 210 upon insertion of contact pin 122into engagement with needle 170 to “count” each successive use, e.g.,each successive engagement of needle electrode assembly 150 to handleassembly 110, of needle electrode assembly 150.

Hub 210 of clocking mechanism 200 further includes visual markings orindicia 270, e.g., numbers, symbols, color-coding, etc., disposed aboutthe outer peripheral surface thereof. Indicia 270 are positioned suchthat the indicium 270 corresponding to the number of uses remaining for(or the condition of) needle electrode assembly 150 is visible throughwindow 160 of housing 152. More specifically, after each use, theincremental rotation of hub 210 relative to housing 152 repositions thenext indicium 270 adjacent window 160, thereby presenting to the userthe condition/status of needle electrode assembly 150. The variousindicia 270 may include numbers corresponding to the number of usesleft. Alternatively or additionally, the various indicia 270 may becolor coded, e.g., to include green indicia indicating that the needleelectrode assembly 150 has several uses left, red indicia indicatingthat the needle electrode assembly 150 is “spent,” or no longer usable,and yellow indicia indicating that only single use (or few uses) isremaining. Other configurations are also contemplated, for example, theuse of a digital indicator (not explicitly shown).

As best shown in FIG. 5A, the three-dimensional track 224 of housing 152is defined annularly about interior surface 220 of housing 152 andincludes one or more sets of alternating channels 225 and bars 226extending from the proximal end of housing 152 towards the distal endthereof. Bars 226 each define an angled distal surface 227. A final bar228 defining a ceiling 229 is disposed adjacent each set of channels 225and bars 226 for retaining clocking mechanism 200 in the locked positionwhen the needle electrode assembly 150 (FIGS. 2-4) has reached its usagelimit. With additional reference to FIGS. 2-4, flanges 212 of hub 210define right-triangle-shaped configurations (although otherconfigurations are contemplated), each having an angled surface 214sloped complementarily to angled distal surfaces 227 of bars 226. Eachflange 212 corresponds to one set of alternating channels 225 and bars226, although only one flange 212 and the corresponding set of channels225 and bars 226 thereof is described (and shown in FIG. 5A) forpurposes of simplicity. Flange 212 is movable through the channels 225and about the bars 226 thereof before ultimately being engaged withinfinal bar 228 to inhibit further use. That is, as will be described ingreater detail below, flange 212 moves proximally and distally throughchannels 225 and about bars 226 to “count” the uses of needle electrodeassembly 150 before being engaged within final bar 228, to inhibitfurther use.

As best shown in FIG. 5B, track 234 defined within internal surface 232of central lumen 230 of hub 210 includes a plurality of slots 235, eachincluding a mouth 236 defining the open end of the slot 235. Mouths 236each define an angled surface 237 configured to mate with acomplementarily-sloped angled surface 126 of angled protrusion 124disposed on the outer periphery of contact pin 122 (see FIGS. 2-4). Withadditional reference to FIGS. 2-4, in use, as will be described ingreater detail below, angled surface 126 of angled protrusion 124 matewith angled surfaces 237 of mouths 236 upon insertion of contact pin 122into central lumen 230 of hub 210 to urge hub 210 distally. Eventually,after hub 210 has been translated sufficiently distally, angled surfaces126, 237 slide past one another such that hub 210 is rotated aboutcontact pin 122 and relative to housing 152. Rotation of hub 210 allowsangled protrusion 126 to move into the adjacent slot 235, thuspermitting hub 210 to return proximally under the bias of spring 250 tofacilitate engagement of contact pin 122 and needle 170 while also“counting” the use of needle electrode assembly 150.

With reference to FIGS. 2-4, in conjunction with FIGS. 5A-5B, theassembly of ablation device 100 and operation of clocking mechanism 200thereof is described, wherein particular features and functions ofclocking mechanism 200 will become more apparent. Initially, as shown inFIG. 2, needle electrode assembly 150 is disposed in an unused positioncondition wherein hub 210 is disposed in a first, or unused rotationalposition and is biased proximally by spring 250 such that flange 212abut shoulder 222 of housing 152. At this point, as shown in FIG. 5A,flange 212 is disposed at position P₁ relative to the respective set ofchannels 225 and bars 226 thereof and the indicium 270 aligned withwindow 160 of housing 152 corresponds to the number of uses of needleelectrode assembly 150 remaining, e.g., three (3) uses. Further, in thisposition, lock fingers 264 are spaced-apart from lock apertures 262.

With particular reference to FIGS. 2-3, in conjunction with FIGS. 5A-5B,in order to engage needle electrode assembly 150 to handle assembly 100needle electrode assembly 150 and handle assembly 100 are approximatedrelative to one another such that contact pin 122 is inserted intocentral lumen 230 of hub 210. As contact pin 122 is inserted intocentral lumen 230 of hub 210, angled protrusion 124 of contact pin 122is moved from position P_(A) to position P_(B) such that angled surfaces126, 237 mate with one another. With angled surfaces 126, 237 matingwith one another, further insertion of contact pin 122 urges angledsurface 126 of protrusion 124 of contact pin 122 further into angledsurface 237 of hub 210, thereby translating hub 210 and needle 170distally relative to housing 152 and against the bias of spring 250.Angled protrusion 124 of contact pin 122 is retained in rotationalposition relative to angled surface 237 of mouth 236 of hub 210 at thispoint, e.g., in position P_(B), since the disposition of flange 212within channel 225 inhibits rotation of hub 210 as hub 210 is translateddistally relative to housing 152.

Continuing with reference to FIGS. 2-3, in conjunction with FIGS. 5A-5B,upon further insertion of contact pin 122 into housing 152 of needleelectrode assembly 150, angled protrusion 124 of contact pin 122 urgeshub 210 further distally such that flange 212 of hub 210 clears thedistal end of the adjacent bar 226, e.g., such that flange 212 isdisposed in position P₂. More specifically, once flange 212 of hub 210is moved distally beyond the adjacent bar 226, hub 210 is no longerinhibited from rotating and, as such, the bias of spring 250 urges hub210 proximally such that angled surfaces 214, 227 slide past one anotherand such that angled surfaces 126, 237 slide past one another to rotatehub 210 relative to housing 152 and contact pin 122 from the firstrotational position to a second rotational position. Rotation of hub 210relative to housing 152 and contact pin 122 moves flange 212 into thenext channel 225 and moves protrusion 124 of contact pin 122 into theadjacent slot 235. With flange 212 disposed at the distal end of thenext channel 225 and with protrusion 124 disposed at the proximal end ofthe adjacent slot 235, hub 210 is no longer inhibited from proximalmovement and, thus is returned proximally under the bias of spring 250and relative to housing 152 and contact pin 122. Accordingly, flange 212is moved relatively proximally through the channel 225 to position P₃and protrusion 124 is moved relatively distally through the slot 235 toposition P_(c). As hub 210 is translated proximally, needle 170 islikewise moved proximally until needle 170 is brought into contact,e.g., surrounding friction-fit contact (or other suitable engagement,e.g., snap-fit), with contact pin 122, thereby mechanically engaginghandle assembly 110 and needle electrode assembly 150 and establishingelectrical communication therebetween. That is, handle assembly 110 andneedle electrode assembly 150 are simultaneously or near-simultaneouslymechanically engaged and electrically coupled to one another, while hub210 is rotated to the second rotational position such that thecorresponding indicium 270 is visible through window 160 of housing 152to indicate the number of uses needle electrode assembly 150 hasremaining, e.g., to indicate two (2) remaining uses.

With handle assembly 110 and needle electrode assembly 150 mechanicallyengaged and electrically coupled to one another, as shown in FIG. 3,ablation device 100 may be used similarly as describe above to treat,e.g., ablate, tissue. After use, needle electrode assembly 150 may bedisengaged from handle assembly 110 via moving handle assembly 110 andneedle electrode assembly 150 apart from one another with sufficienturging (or to otherwise disengage the mechanical engagementtherebetween) to remove contact pin 122 from central lumen 230 of hub210. At this point, hub 210 remains disposed in the second rotationalposition, wherein flange 212 is disposed at position P₃.

Referring still to FIGS. 2-3, in conjunction with FIGS. 5A-5B, aftersterilization, needle electrode assembly 150 may be re-engaged to handleassembly 110 for re-use. The engagement of needle electrode assembly 150and handle assembly 110 is similar to that described above, except thatflange 212 is moved from position P₃, to position P₄ and ultimately toposition P₅; protrusion 124 is moved from position P_(D) to positionP_(E) and ultimately to position P_(F); and hub 210 is rotated from thesecond rotational position to a third rotational position, wherein thecorresponding indicium 270 is visible through window 160, e.g., toindicate that needle electrode assembly 150 has one (1) use remaining.

In the next cycle of use, e.g., upon subsequent engagement of needleelectrode assembly 150 and handle assembly 110 to one another, flange212 is moved from position P₅, to position P₆ and ultimately to positionP₇; protrusion 124 is moved from position P_(G) to position P_(H) andultimately to position P_(I); and hub 210 is rotated from the thirdrotational position to a fourth rotational position, wherein thecorresponding indicium 270 is visible through window 160, e.g., toindicate that needle electrode assembly 150 is “spent.”

Turning now to FIGS. 2-4, in conjunction with FIGS. 5A-5B, since needleelectrode assembly 150, at this point, has reached its usage limit,needle electrode assembly 150 is to be disposed of in favor of a newneedle electrode assembly 150. However, if needle electrode assembly 150is attempted to be re-engaged to handle assembly 110, both mechanicalengagement and electrical coupling are inhibited, thereby inhibitingfurther use of needle electrode assembly 150. More specifically, withflange 212 disposed in position P₇, upon insertion of contact pin 122into central lumen 230 of hub 210, protrusion 124 is moved from positionP_(J) to position P_(K) to urge hub 210 distally. As hub 210 is urgeddistally, flange 212 is translated through the channel 225 until flange212 is disposed distally of final bar 228. With flange 212 disposeddistally of final bar 228, hub 210 is permitted to rotate to a fifth, orlocked rotational position, wherein flange 212 is moved to position P₈to lock hub 210 in a distal position. More specifically, in this lockedposition, as shown in FIG. 5A, ceiling 229 of final bar 228 inhibitsflange 212 and, thus, hub 210 from returning proximally, therebyinhibiting needle 170 from mechanically engaging and electricallycoupling to contact pin 122. Further, in this locked position, as shownin FIG. 4, lock fingers 264 are moved into engagement within lockapertures 262 to inhibit manual overriding of this locked position,e.g., to lock hub 210 in the locked position. Accordingly, needleelectrode assembly 150 is inhibited from further use.

Turing now to FIGS. 6A-6B, another embodiment of an ablation deviceprovided in accordance with the present disclosure is shown generallyidentified by reference numeral 300. Ablation device 300 is similar toablation device 100 (FIGS. 1-5B), described above, and, thus, only thedifferences between ablation device 300 and ablation device 100 (FIGS.1-5B) will be described in detail below, while similarities will only besummarily described or omitted entirely. Further, to the extentconsistent, any of the features of ablation device 100 (FIGS. 1-5B) maysimilarly be used in conjunction with ablation device 300, and viceversa.

Continuing with reference to FIGS. 6A-6B, and to FIG. 6A in particular,ablation device 300 differs from ablation device 100 (FIGS. 1-5A) mainlyin that that clocking mechanism 400 of ablation device 300 includes ahub 410 disposed within housing 352 of needle electrode assembly 350that is transitioned from the first rotational position, to the secondrotational position, to the third rotational position, etc., e.g., eachuse of needle electrode assembly 350 is “counted,” upon circulation ofcooling fluid through hollow interior 374 of needle 370 of needleelectrode assembly 350. The particular features, use, and operation ofablation device 300 are described in greater detail below.

With continued reference to FIG. 6A in particular, ablation device 300generally includes a handle assembly 310 and a needle electrode assembly350 that is releasably engagable with handle assembly 310, e.g., via theengagement of protrusions 354 of housing 352 of needle electrodeassembly 350 within notches 318 defined within housing 312 of handleassembly 310. Housing 312 of handle assembly 310 is configured to coupleto an energy source, e.g., generator 20 (FIG. 1), and a cooling fluidsource, e.g., cooling fluid source 30 (FIG. 1) for supplying energy andcooling fluid, respectively, to needle electrode assembly 350. Morespecifically, an electrical contact pin 322 of handle assembly 310,which ultimately couples to generator 20 (FIG. 1), is configured toextend through a contact pin opening 357 in housing 352 of needleelectrode assembly 350 to electrically couple to correspondingelectrical contact 372 of needle 370 to supply energy and/or controlsignals to needle 370, while fluid supply lumen 330 of handle assembly310, which ultimately couples to cooling fluid source 30 (FIG. 1), isconfigured for engagement within central opening 358 of housing 352 ofneedle electrode assembly 350 to permit the circulation of cooling fluidthrough central lumen 412 of hub 410 and hollow interior 374 of needle370, as indicated by arrows “F,” to maintain needle 370 in a cooledstate during use.

Referring to FIGS. 6A-6B, housing 352 of needle electrode assembly 350defines an internal cavity 355 and includes a contact pin opening 357configured to receive contact pin 322 of handle assembly 310. Anelectrical contact 372 disposed within housing 352 and coupled to needle370 via wire 373 is positioned to couple to electrical contact pin 322upon insertion into housing 352 to electrically couple handle assembly310 and needle electrode assembly 350 to one another. Housing 352 alsoincludes a central opening 358 in communication with cavity 355 that isconfigured to receive fluid supply lumen 330 of handle assembly 310, anda distal opening 359 through which proximal end 371 of needle 370extends. The internal surface 420 of housing 352 that defines cavity 355defines a shoulder 422 and a three-dimensional track 244, similar toshoulder 222 and track 224 of needle electrode assembly 150 (FIGS.2-5A), that are configured to guide translation and rotation of hub 410relative to housing 352. A spring 450 disposed about needle 370 andpositioned within cavity 355 between the distal end of housing 352 andhub 410 is configured to bias hub 410 proximally.

Hub 410 of clocking mechanism 400 is disposed within housing 352 anddefines a central lumen 412 extending therethrough that is configured toestablish communication between fluid supply lumen 330 and hollowinterior 374 of needle 370 for inflow/outflow of cooling fluidtherebetween. Hub 410 is rotationally and longitudinally movablerelative to housing 352 and includes a plurality of angled flanges 414extending outwardly therefrom that are configured to translate thoughtrack 424 of housing 352, similarly as described above with respect toablation device 100 (see FIGS. 2-5B). Hub 410 further includes aplurality of compartments 416 a, 416 b, 416 c, 416 d (although greateror fewer than four compartments may be provided) annularly disposedabout central lumen 412. One or more of the compartments, e.g.,compartments 416 a, 416 b, 416 c (corresponding to the number ofpre-determined uses of needle electrode assembly 350) are hollow and,thus, are configured to permit insertion of contact pin 322 therethroughto permit electrical coupling and mechanical engagement of handleassembly 310 and needle electrode assembly 350 to one another, whilefinal, filled compartment 416 d, when moved into position adjacentcontact pin opening 357 of housing 352, inhibits insertion of contactpin 322 therethrough, thus inhibiting electrical coupling and mechanicalengagement of handle assembly 310 and needle electrode assembly 350 toone another.

Continuing with reference to FIGS. 6A-6B, hub 410 further includes aplurality of angled fins 418 extending inwardly therefrom into centrallumen 412. Angled fins 418 are configured such that, upon distal flow ofcooling fluid from fluid supply lumen 330 through central lumen 412 ofhub 410 and into hollow interior 374 of needle 370, the pressure exertedby the cooling fluid on angled fins 418 urges hub 410 distally againstthe bias of spring 450 and, as a result of the angled configuration offins 418, exerts a rotational force on hub 410. That is, rather thanprotrusions 124 of contact pin 122 urging hub 210 distally and providingrotational force thereto as in ablation device 100 (see FIGS. 2-5B), thecooling fluid flowing through central lumen 412 of hub 410 urges hub 410distally and rotationally loads hub 410. Upon disengagement of needleelectrode assembly 350 from handle assembly 310 after each use, therotationally loaded hub 410 is rotated to the next rotational position.As such, after each use, e.g., each time needle electrode assembly 350is engaged to handle assembly 310, cooling fluid is supplied to needle370, and needle electrode assembly 350 is disengaged from handleassembly 310, a use of needle electrode assembly 350 is “counted” byclocking mechanism 400.

For example, as shown in FIG. 6B, needle electrode assembly 350 may beconfigured for three uses (although needle electrode assembly 350 mayalternatively be configured for greater or fewer uses). In use, hub 410is initially disposed in a first rotational position, wherein firsthollow compartment 416 a is positioned adjacent contact pin opening 357of housing 352, thus permitting insertion of contact pin 322therethrough and into engagement with electrical contact 372 of needleelectrode assembly 350. The insertion of contact pin 322 into housing352 also permits sufficient approximation of housing 312 of handleassembly 310 and housing 352 of needle electrode assembly 350 to permitmechanical engagement therebetween. Upon use, e.g., upon supply ofcooling fluid to needle 370, flanges 414 of hub 410 are translated alongtrack 424 of housing 352 and are rotationally loaded such that, upondisengagement of needle electrode assembly 350 and handle assembly 310after use, hub 410 is rotated to the next, e.g., the second, rotationalposition. As can be appreciated, three uses of needle electrode assembly305 are permitted: the first when hub 410 is disposed in the firstrotational position (wherein first hollow compartment 416 a ispositioned adjacent contact pin opening 357 of housing 352), the secondwhen hub 410 is disposed in the second rotational position (whereinsecond hollow compartment 416 b is positioned adjacent contact pinopening 357 of housing 352), and the third when hub 410 is disposed inthe third rotational position (wherein third hollow compartment 316 c ispositioned adjacent contact pin opening 357 of housing 352). However,once rotated to the fourth rotational position, the final, filledcompartment 416 d inhibits insertion of contact pin 322 into housing 352and, thus, inhibits both electrical coupling and mechanical engagementof needle electrode assembly 350 and handle assembly 310 to one another.That is, once the fourth rotational position is reached, needleelectrode assembly 350 is “spent” and is no longer usable.

From the foregoing and with reference to the various figure drawings,those skilled in the art will appreciate that certain modifications canalso be made to the present disclosure without departing from the scopeof the same. While several embodiments of the disclosure have been shownin the drawings, it is not intended that the disclosure be limitedthereto, as it is intended that the disclosure be as broad in scope asthe art will allow and that the specification be read likewise.Therefore, the above description should not be construed as limiting,but merely as exemplifications of particular embodiments. Those skilledin the art will envision other modifications within the scope and spiritof the claims appended hereto.

1-20. (canceled)
 21. A surgical instrument, comprising: a reusablecomponent; a limited-use component releasably engageable with thereusable component; a clocking mechanism disposed within the limiteduse-component and configured to move incrementally from a first positiontoward a second position upon successive engagements of the reusablecomponent and the limited-use component; a first lockout configured toprevent use of the limited-use component when the clocking mechanism isin the second position; and a second lockout configured to preventmovement of the clocking mechanism from the second position toward thefirst position.
 22. The surgical instrument according to claim 21,wherein electrical communication between the reusable component and thelimited-use component is prevented when the clocking mechanism is in thesecond position.
 23. The surgical instrument according to claim 21,wherein mechanical engagement of the reusable component and thelimited-use component is prevented when the clocking mechanism is in thesecond position.
 24. The surgical instrument according to claim 21,wherein the clocking mechanism includes a hub and a housing, the hubconfigured to move relative to the housing to move the clockingmechanism toward the second position.
 25. The surgical instrumentaccording to claim 21, wherein the limited-use component is configuredfor a pre-determined number of uses, each use corresponding to anincremental movement of the clocking mechanism toward the secondposition.
 26. The surgical instrument according to claim 21, wherein theclocking mechanism includes indicia configured to display a condition ofthe limited-use component.
 27. The surgical instrument according toclaim 26, wherein the indicia displays a number of uses remaining forthe limited-use component.
 28. The surgical instrument according toclaim 21, wherein the reusable component is a handle assembly.
 29. Thesurgical instrument according to claim 21, wherein the limited-usecomponent is an electrode assembly.
 30. The surgical instrumentaccording to claim 21, wherein the limited-use component includes ahollow interior configured to receive a cooling fluid.
 31. The surgicalinstrument according to claim 21, wherein the first lockout is disposedon the limited-use component.
 32. The surgical instrument according toclaim 21, wherein the second lockout is disposed on the limited-usecomponent and configured to engage the reusable component to preventmovement of the clocking mechanism from the second position toward thefirst position.
 33. A surgical instrument, comprising: a handleassembly; and an electrode assembly releasably engageable with thehandle assembly, the electrode assembly including: a clocking mechanismconfigured to move incrementally from one of a plurality of positionstoward a pre-determined one of the plurality of positions uponsuccessive engagements of the handle assembly and the electrodeassembly; a first lockout configured to prevent use of the electrodeassembly when the clocking mechanism is in the pre-determined position;and a second lockout configured to engage the handle assembly to preventmovement of the clocking mechanism from the pre-determined positiontoward one of the other plurality of positions.
 34. The surgicalinstrument according to claim 33, wherein the electrode assemblyincludes a housing, the clocking mechanism configured to moveincrementally within the housing toward the pre-determined position uponsuccessive engagements of the handle assembly and the electrodeassembly.
 35. The surgical instrument according to claim 33, wherein theclocking mechanism is configured to rotate relative to the handleassembly to move incrementally toward the pre-determined position. 36.The surgical instrument according to claim 33, wherein electricalcommunication between the handle assembly and the electrode assembly isprevented when the clocking mechanism is in the pre-determined position.37. The surgical instrument according to claim 33, wherein mechanicalengagement of the handle assembly and the electrode assembly isprevented when the clocking mechanism is in the pre-determined position.38. The surgical instrument according to claim 33, wherein the electrodeassembly is configured for a pre-determined number of uses, each usecorresponding to an incremental movement of the clocking mechanismtoward the pre-determined position.
 39. A system for limiting reuse of asurgical instrument, comprising: a clocking mechanism configured to moveincrementally from one of a plurality of positions toward apre-determined one of the plurality of positions upon successiveengagements of a reusable component and a limited-use component; a firstlockout configured to prevent mechanical engagement and electricalcoupling of the reusable component and the limited-use component whenthe clocking mechanism is in the pre-determined position; and a secondlockout configured to prevent movement of the clocking mechanism fromthe pre-determined position toward one of the other plurality ofpositions.
 40. The system according to claim 39, wherein the limited-usecomponent is configured for a pre-determined number of uses, each usecorresponding to an incremental movement of the clocking mechanismtoward the pre-determined position.